Wednesday, October 31, 2012

How is this for a Halloween metaphor? When it comes to emergencies that threaten our health and safety, we all expect the federal government to come to the rescue, just like the fictional Ghostbusters (from the 1984 movie of the same name) were the ones to call if you find yourself haunted by surly ghosts.

But today, I write about something that is truly scary, the actual and potential loss of life from two unfolding health crises, one caused by nature (Hurricane Sandy) and one by human negligence (a fungal meningitis outbreak caused by an unsafe compounding pharmacy

As much as ideologues on the right argue that the federal government can’t do anything right, that we should just leave protecting our health to free markets—and only if absolute necessary, the states, never ever the feds-- these disasters show us that there is no substitute for calling on the federal government for help.

Here’s the story. When the towns of New Jersey and the streets and tunnels of lower Manhattan and Brooklyn and Staten Island were overrun by Sandy’s water, the officials of those states knew that they couldn’t depend only on their own resources to get through it. Yes, the committed first responders from the local community, the police, firefighters, EMTs, doctors and nurses who came to rescue and care for their neighbors, were essential and deserve everyone's admiration and appreciation. Local and state governments played essential roles in preparing for disaster and organizing relief in the aftermath. But they rightly expected the federal government also to ride to the rescue, in the form of Obama administration and its Federal Emergency Management Agency (FEMA), to provide federal resources. So maligned for its Katrina performance, FEMA is aware that this time it has to pass the test. And so far it has: New Jersey Governor Chris Christie, a champion of small government, declared that “The President has been outstanding in this and so have the folks at FEMA.”

Then there is the fungal meningitis outbreak that has led to 28 deaths, hundreds sickened, and potentially thousands of being at risk of illness or death. This man-made public health disaster appears to be the result of unsanitary and unsafe practices by a compounding pharmacy, the New England Compounding Center (NECC) that is exempt from federal regulation but subject to state regulation. The Massachusetts agency responsible for regulating compounding pharmacies operating in the state said that it “didn’t have the power they needed to keep tabs on NECC.”

So let’s get this straight: the FDA, the federal agency that we rely on to ensure that the prescription drugs that we put into our bodies under a doctor’s orders are safe and effective is barred by federal law from regulating the compounding pharmacies that mix those drugs, and the states by their own admission lack the power they need to keep tabs on them? If there is every a case for the federal government to exercise its constitutional authority to regulate Interstate Commerce (the compounded drugs in question were sold and administered throughout the country), this should be it, yet Congress and federal courts instead has told the FDA to keep its nose out of the compounding pharmacy business?

Sadly, this isn’t the first time people have died because regulation of compounding pharmacies was left left to under-funded state regulators with inadequate enforcement powers to protect us from unsafe compounded drugs.

In observing that our health would be better protected if the FDA was able to regulate compounding pharmacies just as it does drug manufacturers, and that we rely on the federal government to help state and local authorities out when confronted with life-threatening disasters, I am not arguing that all federal regulation is good and necessary or that the federal government always gets it right. Nor am I arguing that there isn’t a role for market competition and state regulation. But I am saying that there are some things that are so critical to our health—the safety of our drugs and our food, the availability of resources to help us when confronted by storms and earthquakes and pandemics and other terrifying things that can kill or sicken us on a massive scale, that there is no substitute for all levels of government--local, state and federal--working together to help the common good. The libertarian/conservative argument that the federal government should just get out of the way and let state and local governments and the private sector go it alone just doesn't hold water. Just ask the people who lost their homes in New York and New Jersey, or the families of loved ones who lost their lives because the FDA isn't allowed to regulate the safety of compounded drugs and the states aren't up to the job.

And although not as immediate or as readily seen on TV, I would add lack of access to health insurance to the list of health crises that require a national response. We know from the Institute of Medicine and Urban Institute that lack of health insurance kills tens of thousands annually, far more than have died from fungal meningitis outbreak of from Hurricane Sandy. We know that leaving the problem to the states to solve doesn’t work—if it did, we wouldn’t have states like Texas where one out of five people are without health insurance, while other states (most notably, Massachusetts) manage to cover almost everyone. If it is true that we need the federal government to protect us from loss of life due to unsafe drugs no matter where in the U.S. we live or where the drugs were mixed or manufactured, shouldn’t we also be protected from loss of life due to lack of access to health insurance, no matter where we live? And if we recognize that states can’t go it alone when it comes to stemming loss of life from natural disasters, shouldn’t we also recognize that states can’t go it alone when it comes to ensuring that we all have access to health insurance, no matter where we live?

The message from Hurricane Sandy and the fungal meningitis outbreak is that we are all in it together. We are safest when Washington partners with state and local governments and the private sector to protect public health and safety. But only the federal government has the reach and resources and ability to organize a national response to national crises, whether it is responding to life-threatening national disasters or ensuring that our prescriptions are safe or guaranteeing that all Americans have access to health insurance.

Today’s questions: So who you gonna call to help protect the public from human- and natural disasters that threaten lives and safety on a grand scale? Only your state and local officials? Your neighbors? The business community? The federal government? How about all of the above?

Tuesday, October 23, 2012

Do you remember the good old days, say 2009, when doctors were able to spend as much time with a patient as needed, when there weren’t any pre-authorization forms to fill out, when no one questioned your performance, and primary care doctors were paid what they are worth? Of course you don’t, because it wasn’t that way. But some physicians critical of ObamaCare have conjured up an imaginary version of the law, one that blames it for everything they don’t like about the healthcare system, like too much red tape and not enough pay, when really most of the things they don’t like pre-dated the law—sometimes by decades!

It is one thing to say that the ACA didn’t do enough to address the daily intrusions that that so aggravate physicians and patients alike, it is another thing to say that ObamaCare caused it all, and that somehow it would all go away if the ACA is repealed.

Here are some examples:

Mandate to adopt ICD-10 codes? Nothing to do with ObamaCare. The ICD-10 mandate was proposed in 2008 by Michael Leavitt, HHS Secretary under the George W. Bush administration, and the legal authority for it comes from the HIPAA legislation enacted in 1996. The Obama administration delayed the rules implementation for another year.

Medicare pay for performance? Started at least three years before ObamaCare. The first version of what is now called the Physicians’ Quality Reporting System began in 2007, three years before ObamaCare was enacted into law. Yes, the ACA continues the program, but it certainly didn’t create it.

Primary care paid too little? Nothing new here, except ObamaCare makes things a bit better. Internists have been objecting to the undervaluation of primary care for decades. A 2006 ACP position paper talked about payment systems “Undervaluing the evaluation and management (E/M) clinical services that are predominately provided by primary care physicians.” But it goes back much further than that. The first public policy that I wrote for internal medicine was a 1981 paper on improving payments for cognitive services, written on behalf of the American Society of Internal Medicine, my then-employer, which merged with ACP in 1998. The fact is that ObamaCare at least starts to make things better for primary care, including an annual 10% Medicare primary care bonus over five years, raising Medicaid payment rates to no less than Medicare’s in 2013 and 2014, and paying 500 advanced primary care practices soon to get an average of $20 per beneficiary per month for care coordination.

Too much insurance company red tape? A growing problem over many decades, but one that ObamaCare at least begins to take on by standardizing some insurance practices. In 1990, the American Society of Internal Medicine wrote a paper titled America’s Health Care System: Strangling in Red Tape and defined the hassle factor as “The increasingly intrusive and often irrational administrative, regulatory review and paperwork burdens being placed on patients and physicians by the Medicare program and other insurers.” It is a theme that ASIM (and certainly since the merger, ACP) have hit upon repeatedly in its advocacy for internal medicine. ObamaCare won’t make the hassle factor go away, and it may add some of its own aggravations, but it also impose fines on insurance companies if they don’t standardize and streamline their enrollment, verification, electronic funds transfer, and authorization requirements to ease hassles on physicians and patients alike.

I get it that many physicians had expected (hoped) that health care reform legislation would have been mostly about getting rid of the “micro” issues that drive them crazy, when ObamaCare is mostly about reducing barriers to people getting health insurance coverage. This disconnect about what physicians find most bothersome about health care, and what ObamaCare is really intended to do, fuels the discontent that some physicians have with the ACA. But at the same time, a fair evaluation of ObamaCare would give it credit for what it does try to accomplish—provide tens of millions more Americans with health insurance. A fair evaluation would acknowledge that it does have provisions to reduce insurance company red tape and increase primary care reimbursements. A fair evaluation would point out the need for more reform that addresses the daily intrusions on the patient-doctor relationship.

But it’s not fair to imagine that everything was hunky-dory for doctors before ObamaCare and that everything will be fine if it goes away. It is not fair to engage in imaginary thinking that ObamaCare is the reason why doctors are drowning in red tape and primary care doctors aren’t getting paid enough. Sure, let’s agree that the ACA doesn’t do enough about these problems--even as it has some things that should help--but let’s not make ObamaCare the imaginary bogeyman for things that have frustrated doctors for many, many years, long before it became the law of the land, things that would still be with us if ObamaCare was repealed.

Today’s question: Do you think it is fair to blame ObamaCare for regulations, hassles, and unfair payment policies that existed long before it became law?

Thursday, October 18, 2012

You should be, but it isn’t the bureaucrats and politicians in Washington that you should be most concerned about. Instead, it is the growing propensity of state legislators to dictate to physicians what they can and can’t say to their patients, what tests they must provide, and what advice they must give to them—the patient’s wishes, the medical evidence, and the physician’s clinical judgment be damned.

Today, the nation’s largest and most influential national medical specialty societies came together to say that enough is enough when it comes to government interference in the patient-doctor relationship.

Joining with his counterparts in the American College of Surgeons, American Academy of Family Physicians, American College of Obstetrics and Gynecology, and American Academy of Pediatrics, ACP’s EVP/CEO Steven Weinberger co-authored an editorial in the New England Journal of Medicine warning against “legislation [that] inappropriately infringe on clinical practice and patient–physician relationships, crossing traditional boundaries and intruding into the realm of medical professionalism.” (Disclosure: I contributed to the piece by providing content review and background information at several stages of the manuscript preparation.)

The article cites four categories laws that do not have the proper “respect for the importance of scientific evidence, patient autonomy, and the patient–physician relationship”:

1. Legislation that “prohibits physicians from discussing with or asking their patients about risk factors that may affect their health or the health of their families, as recommended by evidence-based guidelines of care. In 2011, for example, Florida enacted the Firearm Owners' Privacy Act, which substantially impaired physicians' ability to deliver gun-safety messages to patients.”

2. Laws that “require physicians to discuss specific practices that may not be necessary or appropriate at the time of a specific encounter with a patient, according to the physician's best clinical judgment.” For example, “New York legislation that was enacted in 2010 and became effective in early 2011 requires physicians and other health care practitioners to offer terminally ill patients “information and counseling regarding palliative care and end-of-life options appropriate to the patient, including . . . prognosis, risks and benefits of the various options; and the patient's legal rights to comprehensive pain and symptom management.” The authors note that “This is an area in which one size does not fit all and in which physicians are best able to determine what discussions with patients and families are necessary or appropriate at a given time. Yet failure to comply with the law can result in fines of up to $5,000 for repeat offenses and a jail term of up to 1 year for willful violations.”

3. Laws that “would require physicians to provide — and patients to receive — diagnostic tests or medical interventions whose use is not supported by evidence, including tests or interventions that are invasive and required to be performed even without the patient's consent” citing a Virginia law” requiring women to undergo ultrasonography before having an abortion would have mandated the use of transvaginal ultrasonography for a woman in the very early stages of pregnancy.” “As the Virginia chapter of the American College of Physicians stressed in a letter urging Governor Bob McDonnell to veto the bill, ‘opposition to the legislation does not reflect our opinions individually or collectively on the practice of abortion itself,’” they wrote,“but rather the conviction that ‘this legislation represents a dangerous and unprecedented intrusion by the Commonwealth of Virginia into patient privacy and that it encroaches on the doctor–patient relationship.’”

4. Laws limiting the information that physicians can disclose to patients, to consultants in patient care, or both. Four states (Pennsylvania, Ohio, Colorado, and Texas) have passed legislation relating to disclosure of information about exposure to chemicals used in the process of hydraulic fracturing (“fracking”).

The authors conclude by noting that “Our objection to legislatively mandated health care decisions does not translate into an argument that physicians can do whatever they want. Physicians are still bound by broadly accepted ethical and professional values. The fundamental principles of respect for autonomy, beneficence, nonmaleficence, and justice dictate physicians' actions and behavior and shape the interactions between patients and their physicians. When physicians adhere to these principles, when patients are empowered to make informed decisions about their care, and when legislators avoid inappropriate interference with the patient–physician relationship, we can best balance and serve the health care needs of individual patients and the broader society.”

ACP, in a related statement of principles that pre-dates and helped inform the joint NEJM statement, suggested a series of questions that should be asked of any proposed law to regulate the patient-physician relationship:

“Is the content and information or care consistent with the best available medical evidence on clinical effectiveness and appropriateness and professional standards of care?

Is the proposed law or regulation necessary to achieve public health objectives that directly affect the health of the individual patient, as well as population health, as supported by scientific evidence, and if so, is there any other reasonable way to achieve the same objectives?

Could the presumed basis for a governmental role be better addressed through advisory clinical guidelines developed by professional societies?

Does the content and information or care allow for flexibility based on individual patient circumstances and on the most appropriate time, setting, and means of delivering such information or care?

Is the proposed law or regulation required to achieve a public policy goal –such as protecting public health or encouraging access to needed medical care – without preventing physicians from addressing the healthcare needs of individual patients during specific clinical encounters based on the patients’ own circumstances, and with minimal interference to patient physician relationships?

Does the content and information to be provided facilitate shared decision-making between patients and their physicians, based on the best medical evidence, the physician's knowledge and clinical judgment, and patient values (beliefs and preferences), or would it undermine shared decision-making by specifying content that is forced upon patients and physicians without regard to the best medical evidence, the physician’s clinical judgment and the patient’s wishes?

Is there a process for appeal to accommodate for specific circumstances or changes in medical standards of care?”

It is good that ACP and the other leading national specialty societies have taken a firm stance for patients by objecting to laws that inappropriately inserts government into the relationship between patients and their doctors, but rank-and-file physicians must do their part and hold their state legislators accountable for such laws. Unless and until physicians rise up in broad opposition, legislators will continue to tell you what you can and can’t say or do for your patients, causing grave damage to patient care.

Today’s questions: What do you think of the joint NEJM editorial? What will you do to hold your state legislators accountable?

Wednesday, October 10, 2012

Much of what passes for debate on health care during this election year is focused on the macro side, on big issues like how do we cover the uninsured or restructure Medicare and Medicaid financing. But for all of the talk about vouchers and block grants and insurance mandates, the candidates are missing the micro issues that really matter most to doctors and their patients, which is how health care policy directly affects the quality of the patient-physician encounter.

Talk to physicians around the country, as I regularly do, and these are some of the issues that have them most concerned:

1. Will anyone do anything about the oppressive burden of paperwork and red tape?2. Will the candidates' "macro" proposals for reforming healthcare and entitlements result in more or less paperwork and red tape?3. I already don't have enough time to spend with patients but now I am expected to counsel them on preventive care, lifestyle choices, and the effectiveness of different treatments? How is this possible?4. Electronic health records, great concept, but they don't really streamline the process as advertised, if anything, they just make things more difficult, and besides, they still don't communicate with other systems.5. Everyone wants to measure me, but the measures don't agree with other, they measure the wrong things and they are difficult to report on. And who is measuring the value and effectiveness of the measures themselves?6. Okay, I am supposed to practice cost conscious care, but who is going to stop a lawyer from suing me if I don't give a patient the test they asked for?7. Why is my cognitive care paid so little while procedures and drugs are paid exorbitant rates?8. Payers and government keep imposing more penalties, for not e-prescribing, for not converting to ICD-10, for not meaningfully using my electronic health record, for not complying with their pay for performance schemes. By the time they get done fining me for noncompliance, I will have had to shut my office. Then who will take care of my patients?9. And who has the time to keep track of all of these mandates, incentives, rules, and penalties? I would have to hire a full-time person keep on top of everything. Who is going to pay for that?10. So I am supposed to transform my practice? Well, we all want to do our part, but who is going to pay for that? Besides, my patients seem to think my practice is just fine as it is

Now, I don't really expect Obama and Romney to come out with plans to address these micro health policies. But it is reasonable to hold their macro proposals to a standard of whether they will make all of these aggravations and intrusions better or worse. And at some point, policymakers--no matter their political leanings and plans to reform healthcare at the macro level, need to pay attention to what is happening at the micro patient-doctor encounter level. After all, the boldest of big ideas won't make healthcare better if it makes it harder for physicians to give their patients the care they need.

The goal must be to fashion public policies that improve care at the macro level -- universal access to coverage, spending health care dollars more wisely, and improving healthcare delivery systems -- while also removing barriers at the micro level that intrude on the patient-doctor relationship. Both are equally important.

Today's question: what policies do you think are needed to remove the barriers to the patient-physician relationship?

Wednesday, October 3, 2012

The National Journalreports that jobs and the deficit are likely to dominate tonight's presidential debate, but the most important deficit is the candidates' absence of leadership on unsustainable health care spending, not the federal budget. But before you blame Governor Romney and President Obama, first look in the mirror: politicians don’t level with voters about the sacrifices required to lower health care costs because we would vote them out of office if they did.

Tonight’s 90-minute debate is on domestic issues only. The first 45 minutes will be on the economy, followed by 15-minute segments on health care, the role of government, and governing. But even though health care is supposed to get only its 15 minutes of fame, you really can't talk about the other topics without talking about health care spending. Because, if you solve the health care spending problem, you solve the deficit and you improve the economy. And controlling health care spending involves fundamental questions of how the candidates and the general public view the role of government and approaches to governing. Problem is, we the voters won’t allow either President Obama or Governor Romney to tell us the truth about health care spending, because we wouldn't like what they would have to say, even as we bemoan the lack of straight talk from politicians.

Because this is what an honest answer to the question, "What should the United States do about health care costs and access?" would sound like:

"The simple fact is that we can’t afford our health care system. It is too expensive, even as it leaves tens of millions of us without any health insurance coverage. My opponent and I disagree on how best to lower spending, but there is no disagreement that health spending has to come down—soon, by a great amount, and in ways that none of us will like.

Here is why: spending on health care is the biggest single cause of our exploding budget deficit and debt. We can't balance the budget without reducing how much we spend on Medicare and Medicaid. As our population ages, Medicare is covering more and more people, even as we have fewer younger people supporting it with their taxes. Yes, all of us pay into Medicare during our lifetimes, but get much more from it in return than we put into it.

An average-wage worker pays $60,000 into Medicare in their working years, but receives $170,000 in benefits if a man, $188,000 if a woman. The rest comes from our grown children, but there won’t be enough of them to pay for the many millions of baby-boomers—I am talking about my generation—not without massive tax increases on them. Or we can borrow the money, plunging us more into debt, debt that will also be passed on to our kids.

Our health care system provides excellent care to many of us, and we lead the world in medical advances and innovation. But millions of us do not get good access to care. Forty-six million have no health insurance coverage. And we know that people without health insurance delay getting needed care, and many of them suffer more serious illnesses or die from illnesses that could have been prevented with better access. And the rest of us end up paying for their care. One thing the two of us have in common (pointing to the other candidate) is that we both have signed laws to cover most Americans, in Massachusetts and on a national basis through ObamaCare, yet we and our country remain terribly divided on whether the national law should be implemented, improved, or repealed, and if repealed, what would replace it.

It is possible to cover everyone in the United States and still spend much less, because every other modern industrial country, the countries that we have to compete with in a global economy, have managed to cover all of their citizens at half to two-thirds of what we spend.

And we know that much of the money we spend on health care in the United States is wasted, as much as $700 billion each year, according to studies on medical care, that have little or no benefit for the patient. And we wonder why we can’t afford our health care system!

Here's the rub: solving the health care spending crisis won’t be easy. We will all have to give something, to sacrifice for the greater good. A solution will involve people who can afford paying more for their care. It will involve modest increases in Medicare taxes now rather than huge tax increases or benefit cuts later. It will mean that some drugs, physicians, and hospitals will be paid less. It may mean asking our seniors to wait a few years longer to enroll in Medicare—but if we do, we are obligated to help them get coverage in the meantime so they don’t join the ranks of the uninsured.

It will mean some of health care benefits will have to be curtailed, so we pay only for the things that are most effective in improving health. It will mean changing the way we pay doctors, so we pay them based on how well they help people stay healthy rather than how many services they provide. It will mean forgoing unnecessary tests, like an MRI for back pain, when studies tell us they offer little or no benefit. It will mean finding an alternative to lawsuits against doctors and hospitals that result in unnecessary testing and higher health care costs. It will mean requiring our doctors and hospitals to work together to improve health and lower costs and holding them accountable for the results. It will mean that each of us has to take more responsibility for keeping ourselves well.

In other words, all of us working together to make tough decisions on what we can afford to spend on health care, what we can’t, and how to get the best bang for the buck. The days when everyone can get all of the health care they want, whenever they want, are over, and the sooner we recognize this, the better.

Yet out of all of this, I am confident that through American ingenuity, we can build a better health care system, one that covers and provides good access to care for everyone but at a cost we can afford. Are you with me?"

Now, what would happen to a candidate who made such remarks? The pundits would declare the he lost the senior vote and blew the election. Physicians, hospitals and drug companies would immediately express fierce opposition to cuts. The trial lawyers would go bananas over reforming the med mal system. Ideologues on the right would blast the candidate for proposing government-run rationing, higher taxes and universal coverage, ideologues on the left for cutting benefits, delaying Medicare eligibility and charging patients more.

How likely would it be that the voters would reward the candidate who said something like the above? The Pew Research Center reports that seniors are "highly resistant to Medicare changes" and "A wide majority of seniors (66 percent) said people on Medicare already pay enough of the cost of their health care, compared with 24 percent who said people on Medicare need to be responsible for more costs to keep the program financially secure" and a majority in all age groups say that preserving Medicare and Social Security benefits is more important than reducing the deficit.

So don’t expect honest answers from Governor Romney and President Obama tonight. The deficit in leadership from the candidates on tackling health care costs is because that is exactly what we voters say we want from them.

Today’s questions: Do you agree that there is a deficit in leadership among both candidates in addressing health care costs? And who is to blame, them or us?